Sr Digital Engineer – MES Automation Validation Engineer

Position Overview:

As a M  Designer Modeler PAS‑X you will play a critical role in the design, implementation, and maintenance of our M  using Werum PAS‑X V3 (formerly Korber PAS‑X) with knowledge of Control Systems and experience with Validation process. You will ensure compliance with industry standards and regulations while optimizing production processes.

• Development/Modification/Upgrade/Enhancement of MBRs and GMBRs on PAS‑X V3 (V 3.1 or higher)
• Werum PAS‑X Implementation:
  Design, configuration, and implementation of Werum PAS‑X systems to ensure seamless integration with existing pharmaceutical manufacturing processes.
• System Maintenance:
  Oversee the maintenance, troubleshooting, and optimization of Werum PAS‑X systems to ensure maximum uptime and operational efficiency.
• Compliance:
  Ensure all automation processes comply with industry regulations, including GMPs (Good Manufacturing Practices) and FDA guidelines.
• Documentation:
  Maintain comprehensive documentation of automation processes, including SOPs (Standard Operating Procedures) and change control documentation.

• Training:
  Provide training and support to colleagues and team members to ensure their proficiency in Werum PAS‑X systems.
• Continuous Improvement:
  Identify opportunities for process optimization and efficiency improvements within the automation systems and propose solutions.

• Must have 7-10 years of experience on M  Development within the Pharmaceutical Industry.
• Must have 7-10 years of experience with Werum PAS‑X (formerly Korber PAS‑X) and other pharmaceutical automation systems.
• Must have knowledge of PM  (Parameter Master Batch Records) and PVL (Parameter Value Language)
• Must have strong knowledge of GMP, FDA regulations, and industry best practices.
• Ability to adapt to changing priorities and manage multiple tasks simultaneously.
• Must have Bachelor’s degree in engineering, Computer Science, or a related field.
• Masters degree is a plus.

• Flexible work
• Healthcare including dental, vision, mental health, and well‑being programs
• Financial well‑being programs such as 401(k) and Employee Share Ownership Plan
• Paid time off and paid holidays
• Paid parental leave
• Family building benefits like adoption assistance, surrogacy, and cryopreservation
• Social well‑being benefits like subsidized back‑up child/elder care and tutoring
• Mentoring, coaching and learning programs
• Employee Resource Groups
• Disaster Relief

World leader in engineering and R&D services, Capgemini Engineering combines its broad industry knowledge and cutting‑edge technologies in digital and software to support the convergence of the physical and digital worlds. Coupled with the capabilities of the rest of the Group, it helps clients to accelerate their journey towards Intelligent Industry. Capgemini Engineering has 65,000 engineer and scientist team members in over 30 countries across sectors including Aeronautics, Space, Defense, Naval, Automotive, Rail, Infrastructure & Transportation, Energy, Utilities & Chemicals, Life Sciences, Communications, Semiconductor & Electronics, Industrial & Consumer, Software & Internet.

Capgemini Engineering is an integral part of the Capgemini Group, a global business and technology transformation partner, helping organizations to accelerate their dual transition to a digital and sustainable world, while creating tangible impact for enterprises and society. It is a responsible and diverse group of 340,000 team members in more than 50 countries. With its strong over 55-year heritage, Capgemini is trusted by its clients to unlock the value of technology to address the entire breadth of their business needs.

It delivers end‑to‑end services and solutions leveraging strengths from strategy and design to engineering, all fueled by its market‑leading capabilities in AI, generative AI, cloud and data, combined with its deep industry expertise and partner ecosystem. The Group reported 2024 global revenues of €22.1 billion.

Capgemini is an Equal Opportunity Employer encouraging inclusion in the workplace. All qualified applicants will receive…